Highly regulated drugs or products may carry significant risks to patients. Risk Evaluation & Mitigation Strategies (REMS) may be utilized to minimize the risks of the highly regulated drugs or products. However, periodic assessments of a particular REMS may be needed to determine strategy effectiveness relative to the identified goals.
A survey can be used to assess the effectiveness of a particular REMS. Current survey solutions include telephone surveys or mailed surveys. However, telephone surveys are disruptive, impersonal, and expensive. Likewise, mailed surveys are impersonal, not timely, and have a less than optimal response rate.
Pharmaceutical manufacturers supporting a REMS need a cost-effective, statistically sound method to identify and survey patients or healthcare providers about their knowledge, understanding, and healthcare practices relative to the identified goals of a REMS.